Giving Full Measure to Countermeasures Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare Agents (2004) / Chapter Skim
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1 Ending Half-Measures for Countermeasures: The Challenge and Major Recommendations
1 Ending Half-Measures for Countermeasures: The Challenge and Major Recommendations
Pages 19-43
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From page 19... ...
These factors, together with high regulatory hurdles for obtaining Food and Drug Administration (FDA) approval,1 mean that since the Gulf War of 19901991 DoD has gained no new vaccines and only a few drugs to protect its military personnel against biological warfare agents.
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The committee was not asked to assess the nature or extent of any biological warfare threat or to compare the value to DoD of developing medical countermeasures against biological warfare agents relative to the pursuit of its other obligations. The committee viewed its task as resting on the premise that biological weapons pose a genuine threat to the health of military personnel, and therefore additional FDA-licensed medical countermeasures are urgently needed.
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.4 The upsurge in funding and effort aimed at protecting the civilian population against bioterrorism will undoubtedly result in the development of new technologies and products that can also aid in protecting military personnel against the risks of biological warfare. Although there is considerable overlap in potential threat agents for the battlefield and 4DoD funding for FY 2003 includes program elements for medical biological defense in the Chemical and Biological Defense Program (under budget activities 6.16.5)
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by a single office within the Office of the Secretary of Defense; oversight is to be exercised through the Defense Acquisition Board process November 1993 DoD Directive 6205.3 calls for developing the capability to acquire vaccines against all validated biological warfare threats 1994 Joint Service Agreement for Joint Nuclear, Biological, and Chemical Defense Management; Joint Program Office for Biological Defense chartered (April)
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February 2003 Charter issued for Joint Requirements Office for Chemical, Biological, Radiological, and Nuclear Defense (JRO-CBRN) April 2003 Implementation plan issued for management of the Chemical Biological Defense Program (transfers management of all science and technology activities to the Defense Threat Reduction Agency)
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The military and civilian biodefense programs also differ in their approach to achieving the development, FDA licensure, and manufacture of medical countermeasures. The aim of efforts supported by the increased funding for NIAID is to help ensure that new candidate countermeasures are discovered and developed to a stage at which initial studies of safety and efficacy are promising (i.e., Phase 1 or 2 clinical trials)
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PROBLEMS HINDERING THE DOD EFFORT Although DoD has maintained a research base for medical biodefense countermeasures for many years when few others were working in this field, the committee views the ineffective and inadequate organization and funding of the medical biodefense component of the Chemical and Biological Defense Program as a clear indication that DoD leaders lack an adequate grasp of the commitment, time, scientific expertise, and financial resources required for success in developing vaccines and other pharmaceutical products. Repeated changes in organization and strategy have not addressed those deficiencies, generating instead a flux that has ultimately resulted in disjointed and ineffective management.
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For candidate products to be taken on to human testing, an acceptable IND application must be filed with FDA. The application must include data on safety and biological activity from laboratory and animal tests; manu facturing processes; standards for establishing the safety, purity, potency, and consistency of pilot lots for human use; and detailed plans for the
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Clinical testing begins with Phase 1 studies, which are usually carried out with fewer than 100 people and provide initial data on the safety, pharmacokinetics (how the body handles a product) , and if measurable, biological activity of a candidate product.
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Losing Time and Expertise Through Organizational Adjustments and Changing Strategies Over the past decade, the Chemical and Biological Defense Program has been subject to repeated reorganizations intended to make it function more effectively. These reorganizations have entailed creating brand new organizational units or giving existing units new and unfamiliar responsibilities for managing research and development for vaccines and other pharmaceutical products.
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In 1996, the Joint Vaccine Acquisition Program was established within the Joint Program Office specifically to manage the advanced development and licensure of candidate vaccines by a prime systems contractor. During the spring of 2003, a reorganization affected all phases of the Chemical and Biological Defense Program.
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. USAMRIID is the principal site for DoD's medical biodefense research and a unique resource for animal testing under high-level biosafety conditions, which is necessary at many stages throughout the development process for medical countermeasures.
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The committee sees dismal prospects for successful results (and no prospects for faster results) from the current efforts by DoD's Chemical and Biological Defense Program to produce medical countermeasures.
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Maintaining the status quo only assures a long, costly, and perhaps fruitless wait for new vaccines and therapeutic products. The committee's concerns about DoD's management of its program to develop medical countermeasures against biowarfare agents should come as no surprise to DoD or Congress.
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CBDP, Chemical and Biological Defense Program; DARPA, Defense Advanced Research Projects Agency. SOURCES: DoD, no date, 19972003, 2002; Evans, 2003.
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The medical biodefense component of the Chemical and Biological Defense Program includes activities related to vaccines, therapeutics, and diagnostics. The amounts for FY 2004 are the amounts requested in the President's FY 2004 budget.
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Not only does DTRA have little experience or expertise in biomedical and pharmaceutical research, it adds yet another layer of management between key senior decision makers and the actual performance of research and development tasks for medical countermeasures. RECOMMENDATIONS FOR CHANGE A decision by DoD and national leaders to make DoD's program to develop medical countermeasures against biological warfare agents a genuine priority is the essential first step to set the stage for an effective program.
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Many of these factors distinguish the development process for medical countermeasures from the engineering tasks that have driven the evolution of DoD's system for managing the development of new weapons systems and other products. Furthermore, the present artificial separation between DoD's program
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Moreover, since concerns about biological warfare threats are expanding to include a wider range of naturally occurring and novel biological agents, the line between the two programs is becoming even less distinct and meaningful than it was in the past. Also, Congress should seek guidance from DoD and others to assess the continuing appropriateness of its requirement that DoD devote close to 80 percent of its funding for medical biodefense research to work against biological agents that have been validated by intelligence assessments as near-term threats.7 With a changing understanding of the range of potential threat agents and the ease with which some of them may be created, DoD may require greater flexibility in allocating funds between work on countermeasures against well-established threats and those that may not yet be validated.
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The committee considers the establishment of a newly designated agency as an essential step to accomplish program goals as well as to demonstrate the seriousness of DoD's commitment to its efforts to develop medical countermeasures against biological warfare agents. This action will help make the currently disjointed and poorly functioning program more effective by enhancing its stature and making the program leadership more directly accountable for performance.
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However, DoD has failed to respond adequately to previous reports with similar recommendations for change. The committee believes that the development of biological warfare countermeasures requires the same urgency as work on medical bioterrorism countermeasures; therefore if DoD does not take steps sufficient to make the countermeasure development program effective, the committee recommends, as a last resort, transferring all or part of that responsibility from DoD to an agency responsible for promoting the development of medical countermeasures for bioterrorism defense.
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Many issues must be addressed for DoD to have an effective research and development program for medical countermeasures against biological warfare agents. Those issues and the steps recommended by the committee are discussed in the remainder of this report.
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2002. Department of Defense Chemical and Biological Defense Program.
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Handout to the Institute of Medicine and National Research Council Committee on Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents, Meet ing III. Washington, DC.
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2003. The Acquisition of Drugs and Biologics for Chemical and Biological Warfare Defense: Department of Defense Interactions with the Food and Drug Admin istration.
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